What is a clinical trial bridging study?

The pharmaceutical industry is big business, generating a multi-billion dollar turnover and employing more than 4 million people worldwide. The past three decades have been a boom period for large drug manufacturers as a direct result of the industry’s globalisation.

This success has not been without its challenges, however. One direct issue relates to the regulation of medicines across different global markets. Data from successful clinical trials in one geographical region is not necessarily accurate in another due to differences in ethnicity, which affect how the body reacts to any given compound.

What is a bridging study?

Bridging studies are a relatively recent development, allowing drug manufacturers to operate successfully in different global locations without carrying out lengthy and expensive clinical trials for each ethnic group.

According to the New York Pharma Forum, the delay in drug approval due to ethnic differences was first recognised to be an issue in the Japanese market in the mid 1990s. This was subsequently named the “Japan gap”.

Bridging studies were formulated to extrapolate the data from the original clinical trial before performing the additional tests to determine the effects and safety of the product on the new demographic.

In the fast-paced world of pharmaceuticals, where research and technology are constantly moving forward, the time it takes for a company to bring a new medicine to market is essential and can mean the difference between huge profits and losses. Commissioning a new clinical trial in each region is not economically viable and would be far too time-consuming.

The benefits to both the industry and the consumer are significant. They help drug manufacturers bring new therapies to market at a quicker rate than would otherwise have been possible, consequently reaching more patients and reducing wasted resources and the duplication of data.

Since their advent in the 1990s, these studies have become a vital piece of the puzzle for the pharmaceutical industry, allowing companies more freedom to compete across different geographical locations and subsequently enabling the globalisation of one of the most successful, necessary and lucrative industries on the planet.